Occluding device for occlusion of a body vessel and method for making the same

ABSTRACT

In at least one embodiment of the present invention, a method for making an occluding device for occlusion of fluid flow through a lumen of a body vessel is provided. The method comprises attaching a coating to an embolization coil that is substantially straight. The coating is nominally strained on the substantially straight embolization coil. The embolization coil has a pre-curled tension to facilitate the embolization coil being curled within the lumen of the body vessel when deployed. The embolization coil is restrained from curling until deploying to reduce pre-deployment straining of the coating.

BACKGROUND

1. Field of the Invention

The present invention relates to medical devices. More particularly, theinvention relates to occluding devices for occlusion of fluid flowthrough a body vessel and a method for making the occluding devices.

2. Background of the Invention

Embolization coils have been used as a primary occluding device fortreatment of various arteriovenous malformations (AVM) and varicoceles,as well as for many other arteriovenous abnormalities in the body.Occluding devices are also used to repair abnormal shunts betweenarteries and veins, prevent or reduce blood flow to tumors, stophemorrhaging as a result of trauma, and stabilize aneurysms to preventrupture. Embolization coils may be configured in a variety of sizes withvarying diameters and may be made of several different materialsincluding stainless steel and platinum. Moreover, many embolizationcoils are designed with high tension or stiffness, e.g., between about60 to 100 weight grams, which may provide the coil with a shape memory.This tension is sometimes referred to as a pre-curled tension. Suchcoils tend to reform or recanalize back to a coiled or curled shapeincluding, such as for example, a helical and/or looping configurationbecause of the high tension. Reforming of the coil in the body vesselmay be desirable to enhance occlusion of fluid flow therethrough.

Some of these embolization coils may also be coated for various reasonsincluding inducing more robust and stable occlusions and/or improvinglong term recanalization rates. For example, embolization coils may becoated with a bioresorbable coating, a biocompatible material or anothersuitable material depending on the desired function.

Current manufacturing processes for coating embolization coils typicallyinvolve coating the embolization coil which has a pre-curled tension.The coil is either coated in a curled configuration or allowed to curlafter being coating but prior to being deployed. The coated coil is thensubstantially straightened so as to be advanced through a catheter orother delivery device for introduction into the body vessel. However,some coatings, due to their limited mechanical properties (e.g.stress-strain characteristics), are susceptible to cracking and/orchipping when the coated coil is straightened from its curled shaped.Cracking and/or chipping of the coating, especially prior tointroduction of the embolization coil into the body vessel, may resultin a loss of the coating and a corresponding loss in occludingperformance.

In view of the above, it is apparent that there exists a need for animproved occluding device and a method for making such an occludingdevice.

SUMMARY OF THE INVENTION

In at least one embodiment of the present invention, a method for makingan occluding device for occlusion of fluid flow through a lumen of abody vessel is provided. The method comprises attaching a coating to anembolization coil that is substantially straight. The coating isnominally strained thereon. In order to facilitate the embolization coilbeing curled within the lumen of the body vessel when deployed, theembolization coil has a pre-curled tension. The embolization coil isrestrained from curling until deploying to reduce pre-deploymentstraining of the coating.

In at least one other embodiment of the present invention, an occludingdevice for occlusion of fluid flow through a lumen of a body vessel isprovided. The device comprises an embolization coil having a pre-curledtension to facilitate the embolization coil being curled within thelumen of the body vessel when deployed. Attached to the embolizationcoil is a coating. The coating is nominally strained when theembolization coil is substantially straight. The embolization coil isrestrained from curling until deploying to reduce pre-deploymentstraining of the coating.

In at least one other embodiment of the present invention, anembolization kit for occluding fluid flow through a body vessel isprovided. The kit comprises an occluding device as described in theforegoing paragraph. The kit further comprises a guide catheter. Amicrocatheter is configured to be passed through the guide catheter toposition the microcatheter in the body vessel and to deploy theoccluding device.

Further objects, features, and advantages of the invention will becomeapparent from consideration of the following description and theappended claims when taken in connection with the accompanied drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a side view of an occluding device in accordance with anembodiment of the present invention;

FIG. 1 b is a cross sectional view of the occluding device as depictedin FIG. 1 a;

FIG. 2 a is a side view of an occluding device in accordance withanother embodiment of the present invention;

FIG. 2 b is a cross sectional view of the occluding device as depictedin FIG. 2 a;

FIG. 3 a is a side view of an occluding device in accordance withanother embodiment of the present invention;

FIG. 3 b is a cross sectional view of the occluding device as depictedin FIG. 3 a;

FIG. 4 a is an exploded view of an embolization kit in accordance withan embodiment of the present invention;

FIG. 4 b is a side view of the embolization kit depicted in FIG. 4 a;

FIG. 5 a is a partial side view of the embolization kit with a deployedoccluding device in accordance with an embodiment of the presentinvention;

FIG. 5 b is a partial side view of a deployed occluding device inaccordance with another embodiment of the present invention; and

FIG. 6 is a method for making the occluding device in accordance with anembodiment the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Detailed embodiments of the present invention are disclosed herein. Itis understood however, that the disclosed embodiments are merelyexemplary of the invention and may be embodied in various andalternative forms. The figures are not necessarily to scale; somefigures may be configured to show the details of a particular component.Therefore, specific structural and functional details disclosed hereinare not to be interpreted as limiting but merely as a representativebasis with the claims and for teaching one skilled in the art topractice the present invention.

Examples of the present invention seek to overcome some of the concernsassociated with occluding fluid flow through a body vessel with a coatedoccluding device while minimizing coating loss from the device,especially until deployment of the device into the body vessel.

Employing the principles of the present invention is, for example, anoccluding device for occluding fluid flow through a body vessel, anembolization kit and a method for making the occluding device. Theoccluding device, which is utilized in the embolization kit, includes anembolization coil that has a pre-curled tension to facilitate theembolization coil being curled. (Note—an “embolization coil” isunderstood to be a coil for introduction into a body vessel to reducefluid flow therethrough and will hereinafter be referred to as “coil”).The coil has a coating that was attached thereon when the coil wassubstantially straight. By attaching the coating to the substantiallystraight coil, the coating is nominally or negligible stressed when thecoil is substantially straight and the coating becomes increasinglystressed when the coil curls. Since the strain (e.g. percent elongation)of a material is related to its stress level (e.g. force per unit area)by the material's modulus (e.g. stress/strain), the coil is alsonominally strained when the coil is substantially straight. Nominallystrained hereinafter is understood to mean negligibly, insignificantlyand/or minimally elongated. For example, a coating applied to substratethat is arranged in a first configuration is negligibly or minimallyelongated when the substrate is arranged in the first configuration.This is because the coating is not being significantly stretched orcompressed by the substrate and therefore, the coating has a percentelongation near zero. However, if the substrate is flexed or deformed tobe arranged in a second configuration, the coating is forced to stretchand/or compress with the substrate and thus, will have correspondingpositive and/or negative percent elongation values which deviate fromthose percent elongation values that are near zero. Accordingly, thecoating is no longer nominally strained. Typical methods for measuringstrain levels and percent elongation may be used, such as for example,using various “stress coatings” in combination with microscopy todetermine the corresponding micro-strain values of the coating.

Furthermore, the coil is restrained from curling until deploying inorder to minimize or reduce stressing and straining of the coating. Thecoating, like many materials, cracks and/or chips when it is stressed tostrain beyond its ultimate elongation. Accordingly, by minimizing orreducing straining of the coating, cracking and/or chipping of thecoating is minimized or reduced, thereby minimizing or reducing coatingloss from the coil. Upon deployment, the coil may be positioned at adesignated location in the body vessel and freed to curl such that thecoating may interact with the inside walls of the body vessel to occludethe body vessel.

Referring now to the drawings, FIGS. 1 a and 1 b illustrate anembodiment for imparting a curled shape memory to an occluding device10. A coil 12 of the occluding device 10 has a lumen 16 formedtherethrough. The coil 12 may be made by any apparatus known in the art.For example, the coil 12 may be made by any commercial coil windingmachine such as a roller deflecting apparatus, a mandrel apparatus, orany other suitable means.

A stylet wire 14 with a curled end 15 may be pulled or advanced throughthe lumen 16 such that the coil 12 is advanced around the curled end 15.The curled end 15 plastically strains the advancing coil 12 by straining(e.g. tension and/or compression) the coil 12 beyond its yield point.The plastically deformed coil 12 has a pre-curled tension or curledshape memory, which facilitates or causes the coil 12 to curl unless thecoil 12 is restrained from curling. Other suitable methods known in theart for imparting a curled shaped memory to the coil 12 may also beused.

Referring now to FIGS. 2 a and 2 b, a second stylet wire 18 may beadvanced through the lumen 16 of the pre-curled tensioned coil 12. Thesecond stylet wire 18 is substantially straight. Substantially straightis hereinafter understood to exclude curled shapes, that is, havingcoiled and/or looping configurations, but may include some non-linearconfigurations that are not coiled or looped, which still allow the coil12 to be loaded into a delivery device, such as a microcatheter, withoutfurther straightening of the coil's 12 non-linear configuration. Thesecond stylet wire 18 straightens the coil 12, if the coil 12 has beenallowed to curl, and/or restrains the coil 12 from curling. With thestylet wire 18 disposed through the lumen 16, the coil 12 is alsosubstantially straight. Notably, Applicant has discovered thatstraightening the coil 12 from a curled configuration in this mannerdoes not significantly diminish the curled shape memory of the coil 12.

Referring now to FIGS. 3 a, 3 b and 6, a coating 20 is attached 102 tothe coil 12 while the coil is being restrained substantially straightvia the second stylet wire 18. The coating 12 may be attached to thecoil 12 by applying a coating precursor 22 by any suitably knownprocess, such as for example, spraying, vapor deposition, plating, brushapplying, dipping, casting, or affixing. Moreover, the coating precursor22 may be dried, cured, polymerized and/or coalesced, for example, toform the coating 20. The coating 20 may be used to induce more robustand stable occlusions and/or improve long term recanalization rates. Thecoating 20 may comprise one or more of the following: extracellularmatrix (ECM), such as small intestinal submucosa (SIS), syntheticpolyester, such as DACRON™, nylon, rayon, polyester, PTFE, polyurethane,and bioremoldable material.

As known, ECM is a complex structural entity surrounding and supportingcells found within tissues. More specifically, ECM includes structuralproteins (for example, collagen and elastin), specialized proteins (forexample, fibrillin, fibronectin, and laminin), and proteoglycans, aprotein core to which are attached long chains of repeating disaccharideunits termed glycosaminoglycans.

In one embodiment, the ECM is comprised of SIS. SIS is a resorbable,acellular, naturally occurring tissue matrix composed of extracellularmatrix (ECM) proteins in various growth factors. SIS is derived from theporcine jejunum and functions as a remolding bioscaffold for tissuerepair. SIS has characteristics of an ideal tissue engineeredbiomaterial and can act as a bioscaffold for remolding of many bodytissues including skin, body wall, musculoskeletal structure, urinarybladder, and also supports new blood vessel growth. SIS may be used toinduce site-specific connective tissue structures, which have been shownto completely replace the SIS material in time.

In another embodiment, the precursor 22 of the coating 20 is smallintestinal submucosa gel (SIS gel) including SIS, water, other additivesand digestive chemicals. The SIS gel may be applied to the coil 12 anddried to form the coating 20. In one example, the SIS gel is dried bybeing exposed to a temperature of at least about 30 degrees Celsius (C),and preferably to a temperature of at least about 37° C. In isunderstood that certain commercial ovens can control an oven temperatureto within +/−2° C., and accordingly, the term “about” refers to thetemperature control capabilities of these types of commercial oven.

In a “dry condition,” the coating 20 may be brittle. However, thecoating 20 may become more flexible when contacted with a water-basedfluid, such as for example, body fluids within a body vessel. In oneembodiment, the coil 12 is restrained 104 from curling, via the styletwire 18 or otherwise, until deploying to reduce straining of the coating20 prior to and until deploying, hereinafter referred to aspre-deployment straining of the coating 20. Preferably, reducingpre-deployment straining of the coating 20 eliminates, minimizes orreduces cracking and/or chipping of the coating 20 prior to deploymentof the occluding device 10 into the body vessel. Upon deployment, thecoating 20 is exposed to the body fluids which may soften and/orincrease flexibility (e.g. increase the ultimate elongation) of thecoating 20 such that curling of the coil 12 does not crack and/or chipthe coating 20.

In one embodiment, the coating 20 includes SIS. The SIS may adhere tothe walls of the body vessel and promote body tissue growth. SIS has anatural adherence to connective cells comprising the connective tissueof the walls of a body vessel. If the device 10 is intended topermanently occlude the body vessel, the device 10 is positioned suchthat the host cells of the wall will adhere to the SIS and subsequentlydifferentiate, growing into the SIS and eventually occluding the bodyvessel with the tissue of the walls to which the device 10 wasoriginally adhered. This feature enhances permanent occlusion of thebody vessel.

In another particular embodiment, the coating 20 containing the SIS maybe used to temporarily adhere the device 10 to the walls of the bodyvessel. If the device 10 is only deployed within the body vesseltemporarily, host cells of the walls may adhere to the device, but willnot differentiate, allowing for later retrieval of a device 10 from thebody vessel.

FIGS. 4 a-5 b depicts a body vessel embolization kit 30 which implementsthe occluding device 10 in accordance with one embodiment of the presentinvention. As shown, the kit 30 includes a microcatheter 32 defining acatheter lumen and is preferably made of a soft, flexible material suchas silicone or any other suitable material. Generally, the microcatheter32 has a proximal end 34, a distal end 36, and a plastic adapter or hub38 to receive an apparatus to be advanced therethrough. In one example,the inside diameter of the microcatheter 32 may range between 0.014 and0.027 inches. The kit 30 may further include a guide wire 40 whichprovides the guide catheter 42 a path during insertion of the guidecatheter 42 within a body vessel 44. The size of the guide wire 40 isbased on the inside diameter of the guide catheter 42.

In one embodiment, the guide catheter 42 is a polytetrafluoroethylene(PTFE) guide catheter or sheath for percutaneously introducing themicrocatheter 32 into a body vessel 44. Of course, any suitable materialmay be used without falling beyond the scope or spirit of the presentinvention. The guide catheter 42 may have a size of about 4-French to8-French and allows the microcatheter 32 to be inserted therethrough toa desired location in the body vessel 44. The guide catheter 42 receivesthe microcatheter 32 and provides stability of the microcatheter 32 at adesired location of the body vessel 44. For example, the guide catheter42 may stay stationary within a common visceral artery, e.g., a commonhepatic artery, adding stability to the microcatheter 32 as themicrocatheter 32 is advanced through the guide catheter 42 to a point ofocclusion in a connecting artery, e.g., the left or right hepaticartery.

When the distal end 36 of a microcatheter 32 is at a point of occlusionin the body vessel 44, the occluding device 10 may be loaded at theproximal end 34 of the microcatheter 32. The stylet wire 18 may then beretracted from the lumen 16 of the coil 12 where the coil 12 is thenrestrained from curling by the microcatheter 32, e.g. by the lumen ofthe microcatheter 32. In one example, the occluding device 10 may be“pre-package” within a loading cannula (not shown) and butted up againsthub 38 for delivery into the microcatheter 32. In this scenario, themicrocatheter 32 may be provided with the occluding device 10 having thestylet wire 18 either present or already removed.

The occluding device 10 is advanced through the microcatheter 32 fordeployment through the distal end 36. A push wire 126 may be used tomechanically advance or push the occluding device 10 through themicrocatheter 32. The size of the push wire 126 depends on the diameterof the microcatheter 32.

It is to be understood that the body vessel embolization kit 30described above is merely one example of a kit 30 that may be used todeploy the occluding device 10 into a body vessel 44. Of course, otherkits, assemblies, and systems may be used to deploy any embodiment ofthe occluding device 10 without falling beyond the scope or spirit ofthe present invention.

FIGS. 5 a and 5 b further illustrate two examples of a curled coil 12within the lumen of the body vessel 44. FIG. 5 a illustrates the curledcoil 12 having a looping and folding configuration. FIG. 5 b illustratesthe curled coil 12 having a helical configuration. Other curledconfigurations for the coil 12 that are suitable for occluding a bodyvessel 44 are also intended to be within the scope and spirit of thepresent invention. Moreover, the coil 12 may also include fibers 48extending therefrom, which preferably facilitate occlusion of the bodyvessel 44. The fibers may or may not have the coating 20 attachedthereto.

Applicants performed the following two studies which illustrate theaffect of restraining a coated, pre-curled tensioned coil from curlinguntil being deployed in accordance with at least one embodiment of thepresent invention. In the first study, non-tensioned coils having anextended embolus diameter and length of about 0.035 inches and 5centimeters, respectively, were coated in a straightened configurationby being dipped 2 times in a low concentration of SIS solution followedby 6 dips in a high concentration SIS solution. The low concentration ofSIS solution contained 1 ml of SIS gel and 3 ml of Phosphate BufferedSaline (PBS) and the high concentration of SIS solution contained 1 mlof SIS gel and 1 ml of PBS. Between each of the dipping steps, the coilswere dried by being hung in a vacuum oven at 37 degrees Celsius (C) fortwo hours followed by air-drying in a laminar flow hood for 15 minutes.The drying steps caused the SIS gel to polymerize via crosslinking toform a solid coating layer around each of the coils. The coated coilswere then pushed over a “kinked” stylet wire to pre-curl tension thecoils for curling to a coiled embolus diameter and configuration ofabout 5 millimeters and 3.1 loops respectively. However, pre-tensioningand curling of the coated coils resulted in delamination of nearly 100%of the SIS solid coating layer from the coils. Accordingly, deploymenttesting for evaluating coating loss during deployment was not conducteddue to the extreme pre-deployment coating losses.

In the second study, pre-curled tensioned coils having an extendedembolus diameter and length of about 0.035 inches and 5 centimeters,respectively, and a coiled embolus diameter and configuration of about 5millimeters and 3.1 loops, respectively, were coated by the same dippingand drying process of the first study including using equivalent SISsolution concentrations for the dipping steps. However, the pre-curledtensioned coils were restrained in a straight configuration duringcoating and up until being deployed by having a substantially straightstylet wire positioned through each of the corresponding coil lumens. Onaverage, the coils were each coated with a total of 4.10 mg of SIS gelpost-polymerization to provide about 45.9 microns of SIS coatingthickness around the coils. The coils were then separately loaded intocorresponding catheters, which had been flushed with saline, anddeployed from their respective catheters. After deployment, the loss ofany coating from each of the coils was determined. On average, the coilslost 23.2% of the SIS coating. Notably, however, about 76.8% of the SIScoating still remained on the coils after deployment from the secondstudy, whereas essentially no coating remained on the coils from thefirst study even before they were deployed. Accordingly, Applicantsfound that by restraining the coated, pre-curled tensioned coilsubstantially straight until being deployed that cracking and/orchipping of the coating prior to introduction of the coil into the bodyvessel may be reduced to preferably enhance occluding performance of thecoil.

As a person skilled in the art will readily appreciate, the abovedescription is meant as an illustration of the implementation of theprinciples of this invention. This description is not intended to limitthe scope or application of this invention in that the invention issusceptible to modification, variation, and change, without departingfrom the spirit of this invention, as defined in the following claims.

The invention claimed is:
 1. An occluding device for occlusion of fluidflow through a lumen of a body vessel, the device comprising: anembolization coil having a pre-curled tension to facilitate theembolization coil to be curled within the lumen of the body vessel whendeployed; and a coating attached to the embolization coil by one ofspraying, vapor deposition, plating, brush applying, dipping, andcasting, and being nominally strained when the embolization coil issubstantially straight; and a stylet wire slidably disposed inside theembolization coil to constantly restrained the embolization coil fromcurling during and after attaching the coating until deploying theembolization coil into the body vessel, through which the fluid flow isoccluded, to reduce pre-deployment straining of the coating.
 2. Thedevice according to claim 1, wherein the coating comprises smallintestinal submucosa (SIS).
 3. The device according to claim 1 whereinthe coating becomes increasingly flexible from contact with fluid in thebody vessel when deployed.
 4. The device according to claim 1 whereinthe coating in a “dry condition” is brittle.
 5. The device according toclaim 1 wherein a precursor of the coating is small intestinal submucosa(SIS) gel comprising SIS and water.
 6. An embolization kit for occludingfluid flow through a body vessel, the kit comprising: an occludingdevice including: an embolization coil having a pre-curled tension tofacilitate the embolization coil to be curled within the lumen of thebody vessel when deployed; and a coating attached to the embolizationcoil by one of spraying, vapor deposition, plating, brush applying,dipping, and casting, and being nominally strained when the embolizationcoil is substantially straight; a guide catheter; a microcatheterconfigured to be passed through the guide catheter to position themicrocatheter in the body vessel and to deploy the occluding device; anda stylet wire slidably disposed inside the embolization coil toconstantly restrained the embolization coil from curling during andafter attaching the coating until deploying the embolization coil intothe body vessel, through which the fluid flow is occluded, to reducepre-deployment straining of the coating.
 7. The kit according to claim 6further comprising a pusher wire for advancing the occluding device. 8.The kit according to claim 6 wherein the occluding device is disposedwithin the microcatheter when the kit is in a “pre-packaged condition”,restraining the embolization coil from curling.
 9. The kit according toclaim 6 further comprising a guide wire for guiding the guide catheterin the body vessel.
 10. The kit according to claim 6 further comprisinga stylet wire that is substantially straight and wherein theembolization coil has a lumen formed therethrough, the stylet wire beingcontained in the lumen when the kit is in a “package condition”,restraining the embolization coil from curling.